Stent delivery systems

ABSTRACT

Stent delivery systems including a deployment sheath for the stent, and an anti-catch member positionable adjacent to a proximal end of the deployment sheath and designed to allow the proximal end of the deployment sheath to be passed through the stent without catching on the stent.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/737,673, filed Jan. 8, 2020, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Application Ser. No.62/790,336, filed Jan. 9, 2019, the entirety of which is incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing and using medical devices. More particularly, the presentdisclosure pertains to stents, stent delivery systems, and methods formanufacturing and using such devices and systems.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed formedical use, for example, intravascular use, endoscopic use, and thelike. Some of these devices include expandable stents, delivery devicesand/or systems for expandable stents, and the like. These devices and/orsystems are manufactured by any one of a variety of differentmanufacturing methods and may be used according to any one of a varietyof methods. Of the known medical devices and methods, each has certainadvantages and disadvantages. There is an ongoing need to providealternative medical devices as well as alternative methods formanufacturing and using medical devices.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and usealternatives for expandable stents and/or stent delivery systems.

An example stent delivery system includes: an inner member having adistal end region; a deployment sheath disposed along the distal endregion of the inner member and defining a space between the inner memberand the deployment sheath, the deployment sheath having a proximal end,the inner member and deployment sheath being designed to slide distallyrelative to a stent disposed in the space between the inner member andthe deployment sheath in order to deploy the stent; and an intermediatemember disposed along the inner member, the intermediate memberincluding an anti-catch member, the intermediate member being movablerelative to the deployment sheath such that the anti-catch member ispositionable adjacent to the proximal end of the deployment sheath anddesigned to allow the proximal end of the deployment sheath to be passedthrough the stent without catching on the stent.

Alternatively or additionally to the embodiments above, wherein theanti-catch member includes a tapered outer surface.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member includes a collapsible member.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member includes a self-expanding member.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member includes a conically shaped tubular member.

Alternatively or additionally to any of the embodiments above, whereinthe conically shaped tubular member includes a proximal portion coupledto the intermediate member, and an expandable distal portion.

Alternatively or additionally to any of the embodiments above, whereinthe expandable distal portion includes a plurality of fingers.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member includes a distal portion having a first outerdiameter, and a proximal portion having a second outer diameter, and thefirst outer diameter is greater than the second outer diameter.

Alternatively or additionally to any of the embodiments above, whereinthe deployment sheath includes an inner diameter, and wherein the firstouter diameter of the anti-catch member approaches the inner diameter ofthe deployment sheath.

Alternatively or additionally to any of the embodiments above, whereinthe deployment sheath includes an inner surface, and the anti-catchmember includes an outer surface that engages the inner surface of thedeployment sheath.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member includes a tapered outer surface of a portion ofthe intermediate member.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member is movable relative to the deployment sheath suchthat it includes a first position in which the anti-catch member isspaced from the proximal end of the deployment sheath, and a secondposition in which the anti-catch member is positioned adjacent to theproximal end of the deployment sheath.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member is movable relative to the deployment sheath suchthat it includes a first position in which the anti-catch member isdisposed within the deployment sheath distal of the proximal end of thedeployment sheath, and a second position in which the anti-catch memberis engaged with the deployment sheath at or adjacent the proximal end ofthe deployment sheath.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member includes a constrained configuration where theanti-catch member is disposed within the deployment sheath and anexpanded configuration where at least a portion of the anti-catch memberis disposed outside of the deployment sheath.

Alternatively or additionally to any of the embodiments above, whereinthe anti-catch member includes an inner surface that is designed toengage an outer surface of the deployment sheath.

Alternatively or additionally to any of the embodiments above, furtherincluding a self-expanding stent disposed in the space between the innermember and the deployment sheath.

Alternatively or additionally to any of the embodiments above, where theanti-catch member is disposed in the space between the inner member andthe deployment sheath.

An example stent delivery system includes: an inner member having adistal end region; a deployment sheath coupled to the inner member anddisposed along the distal end region of the inner member, the deploymentsheath having a proximal end; a stent disposed within a space betweenthe inner member and the deployment sheath; an intermediate memberdisposed along the inner member and including an anti-catch member; theinner member and deployment sheath being designed to slide distallyrelative to the stent in order to deploy the stent; and the intermediatemember including the anti-catch member being movable relative to thedeployment sheath such that the anti-catch member includes a firstposition in which the anti-catch member is spaced from the proximal endof the deployment sheath and a second position in which the anti-catchmember is positioned adjacent to the proximal end of the deploymentsheath and is designed to allow the proximal end of the deploymentsheath to be passed through the stent without catching on the stent.

Alternatively or additionally to any of the embodiments above, whereinwhen in the first position, the anti-catch member is disposed within thespace between the inner member and the deployment sheath, and when inthe second position, at least a portion of the anti-catch member isdisposed outside of the deployment sheath.

An example method of deploying a stent includes: delivering a stentdelivery system into the anatomy of a patient, the stent delivery systemincluding; an inner member having a distal end region; a deploymentsheath disposed along the distal end region of the inner member, thedeployment sheath having a proximal end; a stent disposed within a spacebetween the inner member and the deployment sheath; and an intermediatemember disposed along the inner member and including an anti-catchmember. The method includes deploying the stent by sliding the innermember and the deployment sheath distally relative to the stent; movingthe anti-catch member relative to the deployment sheath such that theanti-catch member is positioned adjacent to the proximal end of thedeployment sheath; and passing the deployment sheath through the stent,wherein the anti-catch member is designed to allow the proximal end ofthe deployment sheath to be passed through the stent without catching onthe stent.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIG. 1 is cross sectional side view of a portion of an exampleembodiment of a stent delivery system disposed within a vessel in afirst configuration prior to deployment of the stent;

FIG. 2 is cross sectional side view of the example embodiment of FIG. 1shown in another configuration during deployment of the stent whereinthe stent is partially deployed, and wherein an anti-catch member ispositioned within a deployment sheath spaced from and/or distal to theproximal end of the deployment sheath;

FIG. 3 is partial cross sectional side view of the example embodiment ofFIG. 2 shown in another configuration after deployment of the stent, andthe anti-catch member is positioned within a deployment sheath spacedfrom and/or distal to the proximal end of the deployment sheath, whereinthe vessel, stent, and deployment sheath are shown in cross-section sideviews, while an inner member and an intermediate member including theanti-catch member, are shown in non-cross-sectional side views;

FIG. 4 is partial cross sectional side view of the example embodiment ofFIG. 3 , shown in another configuration after deployment of the stent,where the intermediate member and anti-catch member are moved proximallyrelative to the deployment sheath, and the anti-catch member is in anexpanded state, showing the vessel and stent in cross-sectional sideview, and the delivery system in non-cross sectional side view;

FIG. 5 is partial cross sectional side view of the example embodiment ofFIG. 4 , shown in another configuration with the intermediate member andanti-catch member moved distally relative to the deployment sheath suchthat the anti-catch member is positioned adjacent to the proximal end ofthe deployment sheath;

FIG. 6 is partial cross sectional side view of a portion of anotherexample embodiment of a stent delivery system disposed within a vessel,shown in a configuration after deployment of the stent, and ananti-catch member is positioned within a deployment sheath spaced fromand/or distal to the proximal end of the deployment sheath, wherein thevessel, stent, and deployment sheath are shown in cross-section sideviews, while an inner member and the intermediate member including theanti-catch member are shown in non-cross-sectional side view; and

FIG. 7 is partial cross sectional side view of the example embodiment ofFIG. 6 , shown in another configuration where the intermediate memberand anti-catch member are moved proximally relative to the deploymentsheath such that the anti-catch member is positioned adjacent to theproximal end of the deployment sheath.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit theclaimed invention. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the claimed invention. However, in the interest ofclarity and ease of understanding, while every feature and/or elementmay not be shown in each drawing, the feature(s) and/or element(s) maybe understood to be present regardless, unless otherwise specified.

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure. Other uses of the term“about” (e.g., in a context other than numeric values) may be assumed tohave their ordinary and customary definition(s), as understood from andconsistent with the context of the specification, unless otherwisespecified.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

Although some suitable dimensions, ranges, and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges, and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the disclosedinvention are necessarily shown in each figure or discussed in detailbelow. However, it will be understood that the following discussion mayapply equally to any and/or all of the components for which there aremore than one, unless explicitly stated to the contrary. Additionally,not all instances of some elements or features may be shown in eachfigure for clarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “retract” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan. Other relative terms, such as “axial”,“circumferential”, “longitudinal”, “lateral”, “radial”, etc. and/orvariants thereof generally refer to direction and/or orientationrelative to a central longitudinal axis of the disclosed structure ordevice.

The terms “extent” and/or “maximum extent” may be understood to mean agreatest measurement of a stated or identified dimension, while the term“minimum extent” may be understood to mean a smallest measurement of astated or identified dimension. For example, “outer extent” may beunderstood to mean a maximum outer dimension, “radial extent” may beunderstood to mean a maximum radial dimension, “longitudinal extent” maybe understood to mean a maximum longitudinal dimension, etc. Eachinstance of an “extent” may be different (e.g., axial, longitudinal,lateral, radial, circumferential, etc.) and will be apparent to theskilled person from the context of the individual usage. Generally, an“extent” or “maximum extent” may be considered a greatest possibledimension measured according to the intended usage. Alternatively, a“minimum extent” may be considered a smallest possible dimensionmeasured according to the intended usage. In some instances, an “extent”may generally be measured orthogonally within a plane and/orcross-section, but may be, as will be apparent from the particularcontext, measured differently—such as, but not limited to, angularly,radially, circumferentially (e.g., along an arc), etc.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect the particular feature, structure, orcharacteristic in connection with other embodiments, whether or notexplicitly described, unless clearly stated to the contrary. That is,the various individual elements described below, even if not explicitlyshown in a particular combination, are nevertheless contemplated asbeing combinable or arrangeable with each other to form other additionalembodiments or to complement and/or enrich the described embodiment(s),as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features or configurations. It is to beunderstood that the numerical nomenclature is not intended to belimiting and is exemplary only. In some embodiments, alterations of anddeviations from previously-used numerical nomenclature may be made inthe interest of brevity and clarity. That is, a feature or configurationidentified as a “first” element or configuration may later be referredto as a “second” element or configuration, a “third” element orconfiguration, etc. or may be omitted entirely, and/or a differentfeature or configuration may be referred to as the “first” element orconfiguration. The meaning and/or designation in each instance will beapparent to the skilled practitioner.

Stents, and stent delivery systems are utilized throughout the world inmedical procedures. Many such systems generally have an outer and/ordelivery sheath that constrains the expandable stent in a radiallycontracted, delivery state. The self-expanding stent can be freed fromthe restraint of the delivery sheath by removing the sheath from theconstrained stent, allowing the expandable stent to expand to a radiallyexpanded, deployed state.

For example, some stent delivery system works by proximally retractingthe deployment sheath relative to the stent and/or distally pushing thestent relative to the deployment sheath, causing the stent to begindeployment at its distal end. Once unconstrained by the deploymentsheath, the stent can expand, for example, to force itself against theluminal wall of the body lumen. Such distal deployment systems (DDS) maybe desirable, for example, where precise placement of the distal end ofthe stent is of particular concern.

In some other cases, the stent delivery system works by distallyadvancing the deployment sheath relative to the stent and/or proximallypushing the stent relative to the deployment sheath, causing theproximal end of the stent to deploy first. Such proximal deploymentsystems (PDS) may be desirable, for example, where precise placement ofthe proximal end of the stent is of particular concern.

One common characteristic of proximal deployment systems is that thedelivery sheath extends distally beyond the distal end of the stentduring and/or after deployment of the stent. As such, to remove thedelivery system from the anatomy after deployment of the stent, thedeployment sheath often needs to be withdrawn proximally back throughthe deployed stent.

During proximal withdrawal of the delivery sheath back through thedeployed stent, there is a possibility that a portion of the stent, suchas the distal end of the stent, may be snagged, caught, or disrupted bya portion of the delivery sheath, such as the proximal end of thedelivery sheath. For example, the delivery sheath may have an openproximal end from which the stent was deployed, and this open proximalend may provide a step and/or edge and/or surface that may catch or snagon the stent when withdrawing the delivery sheath back through thedeployed stent. Additionally and/or alternatively, the delivery sheathis typically moved and/or deployed using an inner member having a smalldiameter compared to that of the diameter of the deployment sheath. Thedifference and/or step up in diameter between the inner member and theopen proximal end of the deployment sheath may provide an edge and/orsurface and/or step that may catch or snag the stent when withdrawingthe delivery sheath back through the deployed stent. Catching and/orsnagging the stent during withdrawal of the deployment sheath can createproblems. For example, catching and/or snagging the stent with theproximal end of the deployment sheath during withdrawal could causedifficulties in withdrawal, stent migration, stent or delivery systemdamage, vessel damage, and/or embolism risk if a part of the deliverysystem and/or stent breaks. The risk of catching and/or snagging may beexacerbated if the stent is located along a curve.

Accordingly, there is an ongoing need for improvements in catheters,devices, and/or systems that deliver self-expanding stents, to helpreduce and/or prevent catching and/or snagging of the stent duringwithdrawal of the delivery sheath and/or other components of thedelivery system. As such, some embodiments of the present disclosure mayinclude methods, devices, and/or systems that may be configured ordesigned to help reduce and/or prevent such catching and/or snagging.For example, it may be desirable to provide a stent delivery deviceand/or system that includes an anti-catch member that is positionableadjacent to the proximal end of the deployment sheath and/or otherportions of the delivery system, and is designed to allow portions ofthe delivery system, such as the proximal end of the deployment sheath,to be passed through the stent while reducing or eliminating the risk ofcatching or snagging on the stent.

FIGS. 1-5 show an example embodiment of a stent delivery system 10disposed within a body lumen, such as within a blood vessel 8. The stentdelivery system 10 includes an inner member 14 including a distal endregion 16, and a deployment sheath 20 disposed along the distal endregion 16. The deployment sheath 20 may be coupled to the inner member14, for example, at the distal end 24. A space 19 is defined between theinner member 14 and the deployment sheath 20. An intermediate member 40including an anti-catch member 50 is movably and/or slidably disposedalong the inner member 14 and/or along the deployment sheath 20. A stent30, for delivery, may be disposed in the space 19. This stent deliverysystem 10 is designed to work by distally advancing/translating thedeployment sheath 20 relative to the stent 30 and/or proximallypushing/translating the stent 30 relative to the deployment sheath 20,causing the proximal end of the stent to deploy first. As such, thisstent delivery system 10 is a configured to be a proximal deploymentsystems (PDS).

The stent delivery system 10 may include one or more configurationsduring use, for example: one or more delivery configuration(s), fordelivering a stent 30 to a treatment location; one or more deploymentconfiguration(s) for deploying the stent 30 at the desired treatmentlocation; and one or more withdrawal configuration(s) for removal thedelivery system 10 after deployment of the stent 30. FIGS. 1-5 inprogression show the stent delivery system 10 in various configurationsas it is used to deliver and deploy the stent 30, and then position theanti-catch member 50 adjacent the proximal end of the deployment sheath20 for withdraw the stent deployment system 10. For example, FIG. 1shows the stent delivery system 10 in a delivery configuration. FIGS.2-5 shows the stent delivery system 10 in various other configurations,including deployment configuration(s) at various stages of stentdeployment and positioning of the anti-catch member 50 (e.g. FIGS. 2-4), and withdrawal configuration(s) (e.g. FIG. 5 ).

In some embodiments, the inner member 14 may be and/or included a solidshaft, a tubular member or shaft, such as a hypotube, catheter, etc.,and/or combinations thereof. In some instances, the inner member 14 mayinclude a guidewire lumen 17 for advancing the stent delivery system 10over a guidewire 15 to a treatment location. The inner member 14includes a distal end region 16, a distal end 18, and a proximal region13 that will include a proximal end. The inner member 14 may be coupledto the deployment sheath 20 for movement therewith. For example, adistal end 18 of the inner member 14 may be coupled to the distal end 24of the deployment sheath 20, but other configurations are contemplated.The inner member 14 may be adapted, sized, designed and/or configured tobe used to manipulate and/or move the deployment sheath 20 relative toother components of the system 10, for example, relative to the stent 30and/or intermediate member 40 and/or the anti-catch member 50. In someembodiments, a proximal end of the inner member 14 may include anenlarged flange, a hub, a handle, and/or other suitable means forhandling and/or manipulating the inner member 14 (and therefore thedeployment sheath 30) relative to the stent 30 and/or the intermediatemember 40 or other portions of the device 10. In at least someembodiments, the inner member 14 may be positioned coaxially within theintermediate member 40 and/or the stent 30 and/or the deployment sheath30 and/or other portions of the device 10. Some suitable butnon-limiting materials for the inner member 14 are, for example,metallic materials, polymer materials, composite materials, syntheticmaterials, etc., are described below.

In some embodiments, the deployment sheath 20 may be and/or includes atubular structure or member. The deployment sheath 20 includes a wallhaving an outer surface 28 and an inner surface 26 defining the lumen25. The deployment sheath 20 may be disposed along the distal end region16 of the inner member 14. The deployment sheath 20 may be coupled tothe inner member 14 for movement therewith, and to define the stentspace 19 there between. In the embodiment shown, a distal end 24 of thedeployment sheath 20 is coupled to the distal end 18 of the inner member14, but other attachment configurations are contemplated. The deploymentsheath 20 may be a separate component affixed or attached to the innermember 14 using a suitable attachment technique, or may be part ofand/or of monolithic or unitary construction with the inner member 14(e.g. a singular part or component). The deployment sheath 20 and/or thelumen 25 of the deployment sheath 20 may be sized and/or configured tohouse the stent 30 in a radially collapsed or constrained configuration(e.g. within the space 19). For example, the deployment sheath 20 maysurround the expandable stent 30 to retain the stent 30 in a radiallyconstrained state during delivery of the stent 30 to a target site in abody lumen. The deployment sheath 20 and/or the lumen 25 of thedeployment sheath 20 may also be sized and/or configured to house adistal region 42 of the intermediate member 40 and/or the anti-catchmember 50 (e.g. within the space 19), as discussed and shown herein. Insome embodiments, the deployment sheath 20 may be sized and configuredfor passage through an introducer, a delivery catheter, a guidecatheter, an endoscope, and/or other medical device, for example, duringdelivery. Some suitable but non-limiting materials for the deploymentsheath 20 include, for example, metallic materials, polymer materials,composite materials, synthetic materials, etc., as are described below.

The stent 30, for delivery by the stent delivery system 10, may be aself-expanding stent, and may be configured to shift between a radiallycollapsed configuration when radially constrained and a radiallyexpanded configuration when radially unconstrained. In some embodiments,the stent 30 may be biased toward the radially expanded configuration inan equilibrium state. In some embodiments, the stent 30 may beself-biased toward the radially expanded configuration. The stent 30 mayinclude a distal end 32, a proximal end 34, an outer surface 35, and aninner surface 36 defining a stent lumen 37. As shown in FIG. 1 , thestent 30 may be disposed within the deployment sheath 20 (e.g. withinthe lumen 25 and/or space 19) to retain the stent 30 in a radiallyconstrained state during delivery of the stent 30 to a target site in abody lumen 8.

In some embodiments, the stent 30 may be formed by cutting or removingmaterial from a unitary tubular member, such as by laser cutting orother suitable processes. In some embodiments, the stent 30 may beformed as a braided, woven, and/or knit stent from one or more wires,filaments, etc. The stent 30 may have an overall length suitable for theintended procedure and/or use. For example, the stent 30 may have anoverall length ranging from less than 5 mm to more than 200 mm. In someembodiments, the stent 30 may be formed to an overall diameter or outerextent ranging from 1 mm to 30 mm, depending on the intended usage. Somesuitable but non-limiting materials for the stent 30 include, forexample, metallic materials, polymer materials, composite materials,synthetic materials, etc., are described below.

In some embodiments, the intermediate member 40 may be and/or includes atubular member or shaft, such as a hypotube, catheter, etc., and/orcombinations thereof. The intermediate member 40 may include a tubularstructure including a wall having an outer surface, and an inner surfacedefining a lumen 47. The intermediate member 40 may include the distalregion 42 including a distal end 43, and a proximal region 48 that willinclude a proximal end. In some embodiments, a proximal end of theintermediate member 40 may include an enlarged flange, a hub, a handle,and/or other suitable means for handling and/or manipulating theintermediate member 40 (and therefore the anti-catch member 50 asdescribed herein) relative to the inner member 14 and/or the deploymentsheath 20 and/or the stent 30 and/or other portions of the device 10. Inat least some embodiments, the intermediate member 40 may be positionedcoaxially over the inner member 14, such that a portion of the innermember 14 extends within the lumen 47. The distal region 42 of theintermediate member 40 may also be sized and/or configured to extendwithin and/or be housed within the deployment sheath 20 and/or the lumen25 of the deployment sheath 20, as discussed and shown herein. When sopositioned, the distal region 42 of the intermediate member 40 maycoaxial with the deployment sheath 20.

The intermediate member 40 may be adapted, sized, designed and/orconfigured to be used to manipulate and/or move the anti-catch member 50and/or stent 30 relative to other components of the system 10, forexample, relative to the deployment sheath 20 and/or inner member 14, asis described herein. Additionally and/or alternatively, the intermediatemember 40 may be adapted, sized, designed and/or configured to functionas a stent bed and/or stent rest. For example, in some configurations(such as a delivery configuration and/or a deployment configuration) thedistal region 42 of the intermediate member 40 may be disposed withinthe deployment sheath 20, and the stent 30, in a compressed state withinthe deployment sheath 20, may be disposed around (e.g. surround) aportion of the distal region 42 of the intermediate member 40. Thedistal region 42 of the intermediate member 40 may extend longitudinallywithin the stent lumen 37, and may be coaxial with the stent 30. In someembodiments, the stent 30 may be compressed into engagement with theouter surface of the distal region 42 of the intermediate member 40. Inother embodiments, the stent 30 may be disposed about the distal region42 of the intermediate member 40, but not necessarily compressed intoengagement with the outer surface thereof. Some suitable butnon-limiting materials for the intermediate member 40 are, for example,metallic materials, polymer materials, composite materials, syntheticmaterials, etc., as are described below.

The intermediate member 40 includes the anti-catch member 50. Theanti-catch member 50 may be disposed on and/or along the distal endregion 42 of the intermediate member 40, and may be coupled to theintermediate member 40 for movement therewith. The anti-catch member 50may include a proximal region 54, a proximal end 55, a distal region 56,and a distal end 57. The anti-catch member 50 may include an outersurface 51, and an inner surface 52 defining lumen 53 (which may be incommunication with and/or common with the lumen 47 of the intermediatemember 40).

The anti-catch member 50 may be a separate component affixed or attachedto the intermediate member 40 using a suitable attachment technique, ormay be part of and/or of monolithic or unitary construction with theintermediate member 40 (e.g. a singular part or component). For example,the anti-catch member 50 may be a separate tubular component that isbonded, welded, glued, soldered, heat shrunk or otherwise attached tothe intermediate member 40. In other examples, the anti-catch member 50may be an integral extension, portion, or part of the intermediatemember 40 that includes a widened and/or increased diameter and/ortapered outer surface. In the embodiment shown in FIGS. 1-5 , theanti-catch member 50 is coupled to the distal end 43 of the intermediatemember 40, and extends distally beyond the distal end 43 of theintermediate member 40, but other configurations are contemplated. Forexample, in other embodiments, the anti-catch member 50 may be disposedon and/or along the distal region 42 of the intermediate member 40 suchthat it is spaced from (e.g. is proximal from) and/or overlaps thedistal end 43 of the intermediate member 40. Some suitable butnon-limiting materials for the anti-catch member 50 are, for example,metallic materials, polymer materials, composite materials, syntheticmaterials, etc., as are described below.

The anti-catch member 50 is a feature and/or structure on the distalregion 42 of the intermediate member that may be positioned and/or ispositionable adjacent to a proximal end 23 of the deployment sheath 20after deployment of the stent 30. The anti-catch member 50 may includestructure that, when positioned adjacent to the proximal end 22 of thedeployment sheath 20, is adapted, sized, designed and/or configured tohelp create a transition adjacent to the proximal end 22 of thedeployment sheath 20 that allows the deployment sheath 20 to be passedproximally back through the deployed stent 30 while reducing oreliminating the risk of the proximal end 22 of the deployment sheath 20catching or snagging on the stent 20. The anti-catch member 50 mayinclude one or more of a number of structural features that may aid inthis function.

For example, the anti-catch 50 may include widened diameter structure(e.g. widened diameter relative to the distal region of the intermediatemember 42 and/or distal region of the inner member 14) designed toreduce, close, guard, cover, fill, and/or protect all or a portion ofthe open proximal end of the deployment sheath 20. Additionally and/oralternatively, the anti-catch member 50 may include structure to providea tapered transition adjacent the open proximal end of the deploymentsheath 20. For example, the anti-catch member 50 may provide for atapered transition from the open proximal end 22 of the deploymentsheath 20 to the outer surface of the distal region 42 of theintermediate member 40. The widened diameter and/or tapered structure ofthe anti-catch member 50 (e.g. relative to the distal region of theintermediate member 42), when appropriately positioned adjacent to theproximal end 22 of the deployment sheath 20, may help reduce and/orcover and/or hide and/or eliminating a step and/or a gap and/or an edgeand/or a surface on or adjacent the proximal end 22 of the deploymentsheath 20 that may catch or snag on the stent 30 when withdrawing thedelivery sheath 20 proximally back through the deployed stent 30. Theanti-catch member 50 may generally include at least a portion thereofthat has a diameter that is wider than a diameter of the distal region42 of the intermediate member 40. Additionally, or alternatively, theanti-catch member 50 may generally include a tapered outer surface. Insome embodiments, the anti-catch member 50 may include a widenedgenerally conical and/or cylindrical portion having a tapered outersurface, and having an outer extent or diameter along at least a portionthereof that is greater than the outer extent or diameter of the distalregion 42 of the intermediate member 40 and/or greater than the outerextent or diameter of the distal region 16 of the inner member 14.

Additionally and/or alternatively, the anti-catch member 50 may beadapted, sized, designed and/or configured to function as a distalbumper and/or distal stop for the stent 30. For example, the anti-catchmember 50 may include a widened portion that is designed to engage thedistal end of the stent 30 when the stent is in a constrainedconfiguration within the deployment sheath 30, and prevent distalmovement of the stent 30 relative to and/or with the deployment sheath20 during distal translation of the deployment sheath 20 in the courseof stent deployment. Additionally and/or alternatively, anti-catchmember 50 may be used as a stop or bumper, in combination with theintermediate member 40, to move the stent 30 proximally out of thedeployment sheath 20 in the course of stent deployment.

In some embodiments, all or portions of the anti-catch member 50 may beconfigured to shift between a radially collapsed configuration whenradially constrained and a radially expanded configuration when radiallyunconstrained. The anti-catch member 50, or portions thereof, may beself-expanding. In some embodiments, all or portions of the anti-catchmember 50 may be biased toward the radially expanded configuration in anequilibrium state. In some embodiments, anti-catch member 50, orportions thereof, may be self-biased toward the radially expandedconfiguration. In yet other embodiments, the anti-catch member 50 is notand/or does not include a collapsible/expandable portion or component(some embodiments of which are discussed further herein).

In the embodiment shown in FIGS. 1-5 , at least the distal region 56 ofthe anti-catch member 50 may be configured to shift between a radiallycollapsed configuration when radially constrained by the delivery sheath20 (e.g. as shown in FIGS. 1-3 ) and a radially expanded configurationwhen radially unconstrained by the delivery sheath 20 (as shown in FIGS.4-5 ). In the configurations shown in FIGS. 1-3 , anti-catch member 50may be disposed within the deployment sheath 20 (e.g. within the lumen25 and/or space 19) to retain at least the distal region 56 of theanti-catch member 50 in a radially constrained state (e.g. duringdelivery and/or stent deployment configurations). In the configurationsshown in FIGS. 4 and 5 , the anti-catch member 50 may be disposedoutside of the deployment sheath 20 (e.g. withdrawn proximally from thelumen 25 and/or space 19) and at least the distal region 56 is shiftedto a radially expanded configuration when radially unconstrained by thedelivery sheath 20. The anti-catch member 50 may be a cone and/orconically shaped tubular member including a proximal portion coupled tothe intermediate member 40, and an expandable distal region 56.

In some embodiments, at least a portion of the anti-catch member 50includes a tapered outer surface 51. For example, at least a portion ofthe anti-catch member 50 tapers from a smaller outer diameter to alarger outer diameter as it extends distally. Over at least a region ofthe length of the anti-catch member 50, an outer extent or diameter at amore distal portion of anti-catch member 50 is greater than an outerextent or diameter of the anti-catch member 50 at a more proximalportion thereof, and the transition between these different diametersmay be tapered. The taper may occur at a constant angle relative to thelongitudinal axis, or may occur in a curvilinear fashion. In yet otherembodiments, the taper may occur in a stepwise fashion, for example, atvarying angles along the length thereof and/or including a series oftapered and non-tapered sections. If the anti-catch member 50 isconfigured to shift between a radially collapsed configuration and aradially expanded configuration, the one or more tapers in the outersurface 51 of the anti-catch member 50 may exist in the expandedconfiguration, in the contracted configuration, or both.

For example, in FIGS. 1-3 , the anti-catch member 50 is shown in aradially collapsed configuration, where the proximal region 54 includesa portion having a tapered outer surface (which increases in outerdiameter as it extends distally), but the distal region 56 does not showa tapered outer surface, for example, due to being constrained withinthe deployment sheath 20. However, as shown in FIGS. 4 and 5 , onceunconstrained by the deployment sheath 20, the distal region 56 mayexpand and may then also include one or more portion having a taperedouter surface (which increases in outer diameter as it extendsdistally).

In some embodiments, the anti-catch member 50 may be a tubular and/orconical member having a generally solid wall made of a suitablematerial. In other embodiments, the anti-catch member 50 may be formedas a coiled, braided, woven, and/or knitted feature made from one ormore wires, windings, filaments, etc. Additionally, and/oralternatively, the anti-catch member 50 may be a tubular member that mayinclude one or more slits 60 formed therein, for example, as show inFIGS. 3-5 . The slits may provide for a greater degree of expandabilityand/or flexibility. If a plurality of slits 60 are present, a pluralityof distally extending fingers 61 may be formed in and/or be included inthe anti-catch member, such as in the distal region 56. The plurality offingers 61 may make up the distal region 56 of the anti-catch member,may be expandable, and may include and/or make up at least a portion ofthe tapered outer surface of the anti-catch member 50.

The anti-catch member 50 may include the open distal end 57. Forexample, the anti-catch ember may be and/or include a tubular and/orconical and/or cup shaped member (with or without the slits 60 and/orthe fingers 61) having an opening into the lumen 53 at the distal end 57thereof. In some embodiments, the anti-catch member 50 may include thedistal region 56 adapted, configured and/or sized to engage thedeployment sheath 20, for example, engage the proximal end 22 and/ordistal region 21 of the deployment sheath 20 when positioned adjacentthereto. For example, in some embodiments, the open distal end 57 may bedesigned and/or configured to accept and/or receive and/or engage theproximal end 22 of the deployment sheath 20. For example, as shown inFIG. 5 , when the anti-catch member 50 is expanded, the opening in thedistal end 57 may be sized and configured to accept the proximal end 22of the deployment sheath (see, e.g. FIG. 5 ). In some embodiments, theinner surface 52 of the anti-catch member 50 may engage the outersurface 28 of the deployment sheath 20 at and/or adjacent the proximalend 22 of the deployment sheath. In some embodiments, the inner surface52 of the anti-catch member 50 and/or fingers 61 may include and/or haveapplied thereto a lubricious and/or anti-stick and/or low frictionsurface and/or coating and/or material. Such a surface or coating mayallow for easier engagement and/or disengagement of the anti-catchmember 50 with the deployment sheath 20.

As seen in FIG. 5 , when positioned adjacent to the proximal end 22 ofthe deployment sheath 20, the anti-catch member 50 may function toguard, cover, close, fill, reduce and/or protect all or a portion of theopen proximal end 22 of the deployment sheath 20 and provide a taperedtransition adjacent the open proximal end 22 of the deployment sheath20, for example, to an outer surface 44 of the intermediate member 40.This may help to facilitate smooth removal/proximal withdrawal, andprevent and/or reduce likelihood that the proximal end 22 of thedeployment sheath 20 will catch or snag on the stent duringremoval/proximal withdrawal thereof.

In some embodiments, the anti-catch member 50 may engage the proximalend 22 of the deployment sheath 20 in an end to end and/or abuttingrelationship when disposed adjacent the proximal end 22. For example,the distal end 57 and/or the distal region 56 of the anti-catch member50 may include and/or expand to a diameter that may be sized and/orconfigured to abut and/or to be positioned and/or positional into anabutting relationship with the proximal end 22 of the deployment sheath20. When positioned adjacent to the proximal end 22 of the deploymentsheath 20 in an abutting relationship (e.g. proximal end 22 to distalend 57, the anti-catch member 50 may function to guard, cover, close,fill, reduce and/or protect all or a portion of the open proximal end 22of the deployment sheath 20 and provide a tapered transition adjacentthe open proximal end 22 of the deployment sheath 20, for example, tothe outer surface 44 of the intermediate member 40. This may help tofacilitate smooth removal/proximal withdrawal, and prevent and/or reducelikelihood that the proximal end 22 of the deployment sheath 20 willcatch or snag on the stent during removal/proximal withdrawal thereof.

In some embodiments, the anti-catch member 50 may engage the innersurface 26 of the deployment sheath 20. For example, the deploymentsheath 20 includes a lumen 25 having an inner diameter and defining aninner surface 26. The anti-catch member 50 may include a portion thereof(e.g. distal portion 56) having an outer diameter, and the outerdiameter of the portion of the anti-catch member may approach and/or beabout the same as the inner diameter of the deployment sheath 20 whenthe anti-catch member 50 is disposed therein. As such, there may be somefrictional engagement between the inner surface 26 of the deploymentsheath 20 and the outer surface 51 of the anti-catch member.

As indicated herein, the stent delivery system 10 is designed to work todeploy the stent 30 by distally advancing/translating the deploymentsheath 20 relative to the stent 30 and/or proximally pushing/translatingthe stent 30 relative to the deployment sheath 20, causing the proximalend 34 of the stent 30 to deploy first. As such, the inner member 14 anddeployment sheath 20 may be axially, longitudinally, slidably, and/orrotatably moved and/or translated together relative to the stent 30and/or relative to the intermediate member 40, including the anti-catchmember 50. Such movement will be used to deploy the stent 30, and alsobe used to move the anti-catch member 50 from a position in which theanti-catch member 50 is spaced from the proximal end 22 of thedeployment sheath 20 to a position where the anti-catch member 50 ispositioned adjacent the proximal end 22 of the deployment sheath 20. Aprogressive review and discussion of FIGS. 1-5 can be useful toillustrate the use of the stent deployment system 10 to deliver anddeploy the stent 30, position the anti-catch member 50 adjacent theproximal end of the deployment sheath, and withdraw the stent deploymentsystem 10.

FIG. 1 shows the stent deployment system 10 in a delivery configuration,with the stent 30 in a compressed state fully within the deploymentsheath 20 (e.g. within the lumen 25 and/or space 19), and disposedaround the distal region 42 of the intermediate member 40. Theanti-catch member 50 is disposed distally of the stent 30 within thedeployment sheath 20. As can be appreciate, in this configuration, theanti-catch member 50 is in a position spaced from and/or distal of theproximal end 22 of the deployment sheath 20. In this configuration, thestent deployment system 10, including the stent 30, may be delivered toa treatment location, for example, within the blood vessel 8.

FIG. 2 shows the stent deployment system 10 in another and/or deploymentconfiguration, wherein the stent 30 is partially deployed. Inparticular, FIG. 2 shows relative distal translation of the inner member14 and the deployment sheath 20 relative to the stent 30 and theintermediate member 40 (including the anti-catch member 50). Or stateddifferently, FIG. 2 shows relative proximal translation of the stent 30and intermediate member 40 (including the anti-catch member 50) relativeto the inner member 14 and the deployment sheath 20. A proximal portionof the stent 30 may exert a radially outward force and expand once thedeployment sheath 20 is removed therefrom, thereby permitting theproximal portion of the stent 30 to expand toward the expandedconfiguration. As the proximal portion of the stent 30 radially expands,a distal portion of the stent 30 may be retained in the radiallycollapsed configuration within the deployment sheath 20. For example,the distal portion of the stent 30 is retained in the collapsedconfiguration by the deployment sheath 20. As such, the stent 30 ispartially compressed (distal portion within the deployment sheath 20)and partially expanded (proximal portion outside of the deploymentsheath 20). The stent 30 is still disposed around (e.g. surrounds) thedistal region 42 of the intermediate member 40, and the anti-catchmember 50 is disposed distally of the stent 30 within the deploymentsheath 20. In this configuration, the anti-catch member 50 has movedproximally within the deployment sheath 20, but is also still disposedwithin the deployment sheath 20 in a position spaced from and/or distalof the proximal end 22 of the deployment sheath 20. During thistranslational movement, the anti-catch member 50 may act as a distalstop and/or bumper for the stent 30, preventing distal movement of thestent relative to and/or with the deployment sheath 20.

FIG. 3 shows the stent deployment system 10 in another and/or deploymentconfiguration, wherein the stent 30 is fully deployed. In particular,FIG. 3 shows additional relative distal translation of the inner member14 and the deployment sheath 20 relative to the stent 30 and theintermediate member 40 (including the anti-catch member 50). Or stateddifferently, FIG. 3 shows additional relative proximal translation ofthe stent 30 and intermediate member 40 (including the anti-catch member50) relative to the inner member 14 and the deployment sheath 20. Thisadditional relative translation of the components may release theintermediate and distal portions of the stent 30, progressively, fromthe deployment sheath 20, until the stent 30 is fully deployed, asshown. During this translational movement, the anti-catch member 50 mayagain act as a distal stop and/or bumper for the stent 30, preventingdistal movement of the stent 30 relative to and/or with the deploymentsheath 20. The stent 30 exerts a radially outward force and expands oncethe deployment sheath 20 is removed therefrom. As such, the stent 30 isin a fully expanded configuration, and is deployed within the vessel.The distal region 42 of the intermediate member 40 is still disposedwithin the lumen of the stent 30. The deployment sheath 20 and thedistal region of the 16 of the intermediate member 14 are disposeddistally of the deployed stent 30. The anti-catch member 50 is disposedwithin the deployment sheath 20 (distal of the stent 30). In thisconfiguration, the anti-catch member 50 has moved proximally within thedeployment sheath 20 to a position which is closer to the proximal end22, but is still in a position spaced from and/or distal of the proximalend 22.

FIG. 4 shows the stent deployment system 10 in another and/ortransitional configuration, wherein the stent 30 is fully deployed, andthe anti-catch member 50 has been moved to a position proximal of thedeployment sheath 20. In particular, FIG. 4 shows additional relativedistal translation of the inner member 14 and the deployment sheath 20relative to the intermediate member 40, including the anti-catch member50. Or stated differently, FIG. 4 shows additional relative proximaltranslation of the intermediate member 40, including the anti-catchmember 50, relative to the inner member 14 and the deployment sheath 20.This additional translation of the components may move and/or releasethe anti-catch member 50 from within the deployment sheath 20. In thisembodiment, the anti-catch member 50 is radially collapsible/expandable,and as such, exerts a radially outward force and expands once thedeployment sheath 20 is removed therefrom. As such, the anti-catchmember 50 is in an expanded configuration. The distal region 42 of theintermediate member 40 is still disposed within the lumen of thedeployed stent 30, and the deployment sheath 20 and the distal region ofthe 16 of the intermediate member 14 are disposed distally of thedeployed stent 30. The anti-catch member 50 is disposed proximal of thedeployment sheath 20 and is spaced from (e.g. spaced proximally from)the proximal end 22 of the deployment sheath 20.

FIG. 5 shows the stent deployment system 10 in another and/or withdrawalconfiguration, wherein the stent 30 is fully deployed, and theanti-catch member 50 has been moved to a position adjacent the proximalend 22 of the deployment sheath 20. In particular, FIG. 5 shows relativedistal translation of the intermediate member 40, including theanti-catch member 50, relative to the inner member 14 and the deploymentsheath 20. Or stated differently, FIG. 5 shows relative proximaltranslation of the inner member 14 and the deployment sheath 20 relativeto the intermediate member 40, including the anti-catch member 50. Thistranslation of the components may move the anti-catch member 50 to aposition adjacent the proximal end 22 of the deployment sheath 20. Inthis embodiment, the anti-catch member 50 is an expandable member thatmay engage the proximal end 22 of the deployment sheath 20. The distalregion 42 of the intermediate member 40 is still disposed within thelumen of the deployed stent 30. The deployment sheath 20 and the distalregion of the 16 of the intermediate member 14 are still disposeddistally of the deployed stent 30. To withdraw the delivery system 10from the anatomy, the deployment sheath 20 needs to be withdrawnproximally back through the deployed stent 30. The anti-catch member 50,when positioned adjacent to the proximal end 22 of the deployment sheath20, may function to guard, cover, close, fill, reduce and/or protect allor a portion of the open proximal end 22 of the deployment sheath 20 andprovide a tapered transition adjacent the open proximal end 22 of thedeployment sheath 20 during withdrawal. As such, the deployment sheath20 may be passed through the stent 30, and the anti-catch member isdesigned to allow the proximal end 22 of the deployment sheath 20 to bepassed through the stent 30 without catching on the stent.

As can be appreciate, any of the configurations of the stent deploymentsystem 10 where the anti-catch member 50 is spaced from the proximal end22 of the deployment sheath 20 may be considered a first position, andany of the configurations of the stent deployment system 10 where theanti-catch member is adjacent the proximal end 22 of the deploymentsheath 20 may be considered a second position, and that the anti-catchmember is movable relative to the deployment sheath 20 such that it canbe transitioned from a first position to a second position.

FIGS. 6 and 7 illustrate another example embodiment of a stent deliverysystem similar in form and function to stent delivery system shown anddescribed with reference to FIGS. 1-5 , wherein similarly namedstructures and/or similarly numbered structures may be similar in form,function and material as those discussed elsewhere herein. In thisembodiment, however, the intermediate member 40 includes an anti-catchmember 150 that is not collapsible/expandable. The anti-catch member 150may be disposed on and/or along the distal end region 42 of theintermediate member 40, and may be coupled to the intermediate member 40for movement therewith. The anti-catch member 150 may include a proximalregion 154, a proximal end 155, a distal region 156, a distal end 157,and an outer surface 151. Some suitable but non-limiting materials forthe anti-catch member 150 are, for example, metallic materials, polymermaterials, composite materials, synthetic materials, etc., as aredescribed below.

The anti-catch member 150 includes the tapered outer surface 151. Forexample, at least a portion of the anti-catch member 150 tapers from asmaller outer diameter to a larger outer diameter as it extendsdistally. Over at least a region of the length of the anti-catch member150, an outer extent or diameter at a more distal portion of anti-catchmember 150 is greater than an outer extent or diameter of the anti-catchmember 150 at a more proximal portion thereof, and the transitionbetween these different diameters may be tapered. As such, theanti-catch member 150 includes the distal portion 156 having a firstouter diameter, and the proximal portion 154 having a second outerdiameter, and the first outer diameter is greater than the second outerdiameter. As can be appreciated, the anti-catch member 151 may becharacterized as including a conically shaped tubular member. The tapermay occur at a constant angle relative to the longitudinal axis, or mayoccur in a curvilinear fashion. In some embodiments, the taper may occurin a stepwise fashion, for example at varying angles along the lengththereof.

As such, in some embodiments, the anti-catch member 150 may be a featureon and/or built onto the distal region of the intermediate member 40that tapers to a thicker diameter as it extends distally. This thickerdiameter and taper may help to mitigate the size and/or abruptness ofthe transition at the proximal end 22 of the deployment sheath 20, andmay be designed to allow the proximal end 22 of the deployment sheath 20to be passed through the stent 30 without catching on the stent.

The anti-catch member 150 may be a separate component affixed orattached to the intermediate member 40 using a suitable attachmenttechnique, or may be part of and/or of monolithic or unitaryconstruction with the intermediate member 40 (e.g. a singular part orcomponent). For example, the anti-catch member 150 may be a separatetubular component that is bonded, welded, glued, soldered, heat shrunkor otherwise attached to the intermediate member 40. In other examples,the anti-catch member 150 may be an integral extension, portion, or partof the intermediate member 40 that includes a widened and/or increaseddiameter and/or tapered outer surface. In some embodiments, for example,as shown, the anti-catch member 150 is coupled to the distal end 43 ofthe intermediate member 40, and extends distally beyond the distal end43 of the intermediate member 40, but other configurations arecontemplated. For example, in other embodiments, the anti-catch member150 may be disposed on and/or along the distal end region 42 of theintermediate member 40 such that it is spaced from (e.g. is proximalfrom) and/or overlaps the distal end 43 of the intermediate member 40.

FIG. 6 shows the stent deployment system 110 in a deploymentconfiguration similar to that shown in FIG. 3 , wherein the stent 30 hasalready been fully deployed. It is noted that the stent deploymentsystem 110 as shown in FIG. 6 may have transitioned to the configurationshown from an initial and/or delivery configuration (similar to thatshown in FIG. 1 ), where stent 30 would be in a compressed statedisposed fully within the deployment sheath 20, through a partialdeployment configuration (similar to that shown in FIG. 2 ), wherein thestent 30 is partially deployed. This transition would occur through therelative translation of the components as discussed herein. It is alsonoted that in these previous configurations (e.g. similar to FIGS. 1 and2 ), the anti-catch member 150 would be disposed distally of the stent30 within the deployment sheath 20, spaced from and/or distal to theproximal end 22 of the deployment sheath 20.

FIG. 6 then shows relative distal translation of the inner member 14 andthe deployment sheath 20 relative to the stent 30 and the intermediatemember 40 (including the anti-catch member 150). Or stated differently,FIG. 6 shows additional relative proximal translation of the stent 30and intermediate member 40 (including the anti-catch member 150)relative to the inner member 14 and the deployment sheath 20. Thisadditional relative translation of the components may release theintermediate and distal portions of the stent 30, progressively, fromthe deployment sheath 20, until the stent is fully deployed, as shown.During this translational movement, the anti-catch member 150 may againact as a distal stop and/or bumper for the stent 30, preventing distalmovement of the stent 30 relative to and/or within the deployment sheath20. The stent 30 exerts a radially outward force and expands once thedeployment sheath 20 is removed therefrom. As such, the stent 30 is in afully expanded configuration, and is deployed within the vessel. Thedistal region 42 of the intermediate member 40 is still disposed withinthe lumen of the stent 30. The deployment sheath 20 and the distalregion of the 16 of the intermediate member 14 are disposed distally ofthe deployed stent 30. The anti-catch member 150 is disposed within thedeployment sheath 20 (distal of the stent 30). In this configuration,the anti-catch member 150 has moved proximally within the deploymentsheath 20 to a position which is closer to the proximal end 22, but isstill in a position spaced from and/or distal of the proximal end 22.

FIG. 7 shows the stent deployment system 110 in another and/orwithdrawal configuration, wherein the stent 30 is fully deployed, andthe anti-catch member 150 has been moved to a position adjacent theproximal end 22 of the deployment sheath 20. In particular, FIG. 7 showsrelative distal translation of the intermediate member 40, including theanti-catch member 150, relative to the inner member 14 and thedeployment sheath 20. Or stated differently, FIG. 7 shows relativeproximal translation of the inner member 14 and the deployment sheath 20relative to the intermediate member 40, including the anti-catch member150. This translation of the components may move the anti-catch member150 to a position adjacent the proximal end 22 of the deployment sheath20. In this embodiment, the anti-catch member 150 is not an expandablemember, but provides a tapered transition adjacent the proximal end 22of the deployment sheath 20. The distal region 42 of the intermediatemember 40 is still disposed within the lumen of the deployed stent 30.The deployment sheath 20 and the distal region of the 16 of theintermediate member 14 are still disposed distally of the deployed stent30. To withdraw the delivery system 10 from the anatomy, the deploymentsheath 20 needs to be withdrawn proximally back through the deployedstent 30. The anti-catch member 150, when positioned adjacent to theproximal end 22 of the deployment sheath 20, may function to guard,cover, close, fill, reduce and/or protect all or a portion of the openproximal end 22 of the deployment sheath 20 and provide a taperedtransition adjacent the open proximal end 22 of the deployment sheath 20during withdrawal. As such, the deployment sheath 20 may be passedthrough the stent 30, and the anti-catch member 150 is designed to allowthe proximal end 22 of the deployment sheath 20 to be passed through thestent 30 without catching on the stent.

As can be appreciate, any of the configurations of the stent deploymentsystem 110 where the anti-catch member 150 is spaced from the proximalend 22 of the deployment sheath 20 may be considered a first position,and any of the configurations of the stent deployment system 10 wherethe anti-catch member 150 is adjacent the proximal end 22 of thedeployment sheath 20 may be considered a second position, and that theanti-catch member 150 is movable relative to the deployment sheath 20such that it can be transitioned from a first position to a secondposition.

The materials that can be used for the various components of the stentdelivery systems (e.g. 10 and 110) disclosed herein may include thosecommonly associated with medical devices. For simplicity purposes, thefollowing discussion makes reference to stent delivery systems (10 and110). However, this is not intended to limit the devices and methodsdescribed herein, as the discussion may be applied to other similarstent delivery systems and/or components thereof.

The stent delivery systems 10 and 110 and/or other components thereofmay be made from a metal, metal alloy, polymer (some examples of whichare disclosed below), a metal-polymer composite, ceramics, combinationsthereof, and the like, or other suitable material. Some examples ofsuitable polymers may include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP),polyoxymethylene (POM, for example, DELRIN® available from DuPont),polyether block ester, polyurethane (for example, Polyurethane 85A),polypropylene (PP), polyvinylchloride (PVC), polyether-ester (forexample, ARNITEL® available from DSM Engineering Plastics), ether orester based copolymers (for example, butylene/poly(alkylene ether)phthalate and/or other polyester elastomers such as HYTREL® availablefrom DuPont), polyamide (for example, DURETHAN® available from Bayer orCRISTAMID® available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

Some examples of suitable metals and metal alloys include stainlesssteel, such as 304V, 304L, and 316LV stainless steel; mild steel;nickel-titanium alloy such as linear-elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium-molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 suchas HASTELLOY® ALLOY B2®), other nickel-chromium alloys, othernickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-ironalloys, other nickel-copper alloys, other nickel-tungsten or tungstenalloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenumalloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like);platinum enriched stainless steel; titanium; combinations thereof; andthe like; or any other suitable material.

In at least some embodiments, portions or all of the stent deliverysystems 10 and/or 110 and/or components thereof may also be doped with,made of, or otherwise include a radiopaque material. Radiopaquematerials are understood to be materials capable of producing arelatively bright image on a fluoroscopy screen or another imagingtechnique during a medical procedure. This relatively bright image aidsthe user of the stent delivery systems and/or other components thereofin determining its location. Some examples of radiopaque materials caninclude, but are not limited to, gold, platinum, palladium, tantalum,tungsten alloy, polymer material loaded with a radiopaque filler, andthe like. Additionally, other radiopaque marker bands and/or coils mayalso be incorporated into the design of the stent delivery systemsand/or other components thereof to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the stent delivery systems and/or othercomponents thereof. For example, the stent delivery systems and/or othercomponents thereof, or portions thereof, may be made of a material thatdoes not substantially distort the image and create substantialartifacts (e.g., gaps in the image). Certain ferromagnetic materials,for example, may not be suitable because they may create artifacts in anMRI image. The stent delivery systems and/or other components thereof,or portions thereof, may also be made from a material that the MRImachine can image. Some materials that exhibit these characteristicsinclude, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g.,UNS: R30003 such as ELGILOY®, PHYNOX®, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nitinol, and the like, and others.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A stent delivery system, comprising: an innermember; a deployment sheath coupled to the inner member, the deploymentsheath disposed along the inner member and defining a space between adistal region of the inner member and the deployment sheath, the spaceconfigured to contain a stent; and an intermediate member disposedradially between the inner member and the deployment sheath andconfigured to extend through the stent when the stent is within thedeployment sheath, the intermediate member including an enlarged region,the intermediate member being movable relative to the deployment sheathsuch that the enlarged region is positionable adjacent to a proximal endof the deployment sheath and configured to allow the proximal end of thedeployment sheath to be passed through the stent without engaging thestent.
 2. The stent delivery system of claim 1, wherein the deploymentsheath is coupled to the inner member such that movement of the innermember moves the deployment sheath.
 3. The stent delivery system ofclaim 2, wherein a distal end of the inner member is fixed to a distalend of the deployment sheath.
 4. The stent delivery system of claim 1,wherein the space between the distal region of the inner member and thedeployment sheath is configured to contain an entirety of the stent. 5.The stent delivery system of claim 1, wherein the enlarged region of theintermediate member includes a plurality of longitudinal slits forming aplurality of fingers.
 6. The stent delivery system of claim 1, whereinthe enlarged region of the intermediate member includes a conicalproximal portion and a cylindrical distal portion.
 7. The stent deliverysystem of claim 1, wherein the enlarged region of the intermediatemember is self-expanding.
 8. The stent delivery system of claim 7,wherein the enlarged region of the intermediate member is configured tomove between a collapsed configuration when positioned inside thedeployment sheath, and an expanded configuration when the enlargedregion is withdrawn proximally from the deployment sheath.
 9. The stentdelivery system of claim 8, wherein when in the collapsed configuration,an outer diameter of the enlarged region is less than an inner diameterof the deployment sheath, and when in the expanded configuration, aninner diameter of the enlarged region is larger than an outer diameterof the deployment sheath.
 10. The stent delivery system of claim 9,wherein the enlarged region includes an open distal end.
 11. The stentdelivery system of claim 10, wherein when in the expanded configuration,the intermediate member may be advanced distally such that a distalportion of the enlarged region extends over the proximal end of thedeployment sheath.
 12. The stent delivery system of claim 1, furtherincluding a self-expanding stent disposed in the space between the innermember and the deployment sheath.
 13. The stent delivery system of claim12, wherein the enlarged region of the intermediate member is positionedin the space between the inner member and the deployment sheath anddistal of the stent.
 14. A stent delivery system, comprising: an innermember; a deployment sheath coupled to the inner member, the deploymentsheath disposed along the inner member and defining a space between adistal region of the inner member and the deployment sheath, the spaceconfigured to contain a stent; and an intermediate member disposedradially between the inner member and the deployment sheath andconfigured to extend through the stent when the stent is within thedeployment sheath, the intermediate member including an expandabledistal region that is movable between a collapsed configuration whenpositioned inside the deployment sheath, and an expanded configurationwhen the expandable distal region is withdrawn proximally from thedeployment sheath, wherein when in the expanded configuration, an outerdiameter of the expandable distal region is greater than an outerdiameter of a proximal end of the deployment sheath.
 15. The stentdelivery system of claim 14, wherein the space between the distal regionof the inner member and the deployment sheath is configured to containan entirety of the stent.
 16. The stent delivery system of claim 14,wherein the expandable distal region of the intermediate member includesa plurality of longitudinal slits forming a plurality of fingers. 17.The stent delivery system of claim 14, wherein when in the expandedconfiguration, the intermediate member may be advanced distally suchthat a distal portion of the expandable distal region extends over theproximal end of the deployment sheath.
 18. The stent delivery system ofclaim 14, further including a self-expanding stent disposed in the spacebetween the inner member and the deployment sheath.
 19. The stentdelivery system of claim 18, wherein the expandable distal region of theintermediate member is positioned in the space between the inner memberand the deployment sheath and distal of the stent.
 20. A stent deliverysystem, comprising: an inner member; a deployment sheath coupled to theinner member, the deployment sheath disposed along the inner member anddefining a space between a distal region of the inner member and thedeployment sheath; an intermediate member disposed radially between theinner member and the deployment sheath, the intermediate memberincluding an enlarged region; and a stent disposed in the space betweenthe inner member and the deployment sheath, proximal of the enlargedregion of the intermediate member, wherein the intermediate memberextends through the stent; wherein the intermediate member is movablerelative to the deployment sheath such that after the stent is deployed,the enlarged region is positionable adjacent to a proximal end of thedeployment sheath and configured to allow the proximal end of thedeployment sheath to be passed through the stent without engaging thestent.